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Advanced practice registered nurses in cardiology
In case you didn’t notice, our clinical practice has been reinforced by a entirely new class of performers who have become essential to our daily activities.
They are Advanced Practice Registered Nurses, whose role has evolved over the last 50 years from the Coronary Care Unit nurse with special training in coronary care to an array of well-trained women and men who have received both Bachelor’s and Master’s degrees in Nursing.
As a further extension of their training, many are now going on to achieve a further doctorate degree in nursing after 90 hours of postgraduate classes at certified academic centers and additional clinical experience in a variety of fields, including cardiology. The nurses completing those programs will be certified and licensed as APRNs. They come to our practice with remarkable experience and expertise in arrhythmia and heart failure management, as well as interventional skills, on top of wide experience in the management of patients in critical care units. Their integration into comprehensive and collaborative cardiac care raises challenges to and opportunities for the cardiologist.
A recent survey of large cardiology clinics initiated by the Summit Medical Group assessed the role of the APRN in the care of patients both in hospitals and in clinics. It reported that in many of cardiology clinics surveyed, APRNs provide an expanding role in patient care leading to variable relationships between the patient and the cardiologist. In some settings, the APRNs often function independent of physician interaction, initiating the patients’ entrance into the clinic and managing their follow-up. In other situations, they may be supervised by a cardiologist and their future laboratory studies and therapy are completely managed by the APRN, who functions as a professional associate of a physician. However, in many situations the cardiologist may have little or no contact with the patient.
While the APRN is seeing the patient, the cardiologists often are seeing their own patients or, more likely, are involved with maintaining the electronic medical record or performing or interpreting tests that are usually reimbursed at a fee that is a multiple of that received for a patient visit alone. Much of this is carried out under the heading of “coordinated care” and is managed in a multidisciplinary matrix in which many specialists and APRNs play a role in the care of the patient. In this setting, the doctor has become manager of a diverse group of support staff, including APRNs, and may be increasingly remote from direct patient care. My medical colleagues find the process as a way to increase the patient “pass through.” Many patients presume that the APRN is a reasonable alternative to a busy cardiologist or are interacting with their cardiologist.
As doctors, we are divesting ourselves from the one thing that sets us apart and makes us unique in the health care system; the ability to interact with patients in a comprehensive way. We seem to be on the slippery slope to medical obsolescence, soon to be replaced by staff who can triage our patients to the next appropriate test. Both the patient and doctor seem to have slipped into a Walmart-like world where expedience dominates over skill and shortcuts are the alternative to thoughtful personal physician-patient interaction.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
In case you didn’t notice, our clinical practice has been reinforced by a entirely new class of performers who have become essential to our daily activities.
They are Advanced Practice Registered Nurses, whose role has evolved over the last 50 years from the Coronary Care Unit nurse with special training in coronary care to an array of well-trained women and men who have received both Bachelor’s and Master’s degrees in Nursing.
As a further extension of their training, many are now going on to achieve a further doctorate degree in nursing after 90 hours of postgraduate classes at certified academic centers and additional clinical experience in a variety of fields, including cardiology. The nurses completing those programs will be certified and licensed as APRNs. They come to our practice with remarkable experience and expertise in arrhythmia and heart failure management, as well as interventional skills, on top of wide experience in the management of patients in critical care units. Their integration into comprehensive and collaborative cardiac care raises challenges to and opportunities for the cardiologist.
A recent survey of large cardiology clinics initiated by the Summit Medical Group assessed the role of the APRN in the care of patients both in hospitals and in clinics. It reported that in many of cardiology clinics surveyed, APRNs provide an expanding role in patient care leading to variable relationships between the patient and the cardiologist. In some settings, the APRNs often function independent of physician interaction, initiating the patients’ entrance into the clinic and managing their follow-up. In other situations, they may be supervised by a cardiologist and their future laboratory studies and therapy are completely managed by the APRN, who functions as a professional associate of a physician. However, in many situations the cardiologist may have little or no contact with the patient.
While the APRN is seeing the patient, the cardiologists often are seeing their own patients or, more likely, are involved with maintaining the electronic medical record or performing or interpreting tests that are usually reimbursed at a fee that is a multiple of that received for a patient visit alone. Much of this is carried out under the heading of “coordinated care” and is managed in a multidisciplinary matrix in which many specialists and APRNs play a role in the care of the patient. In this setting, the doctor has become manager of a diverse group of support staff, including APRNs, and may be increasingly remote from direct patient care. My medical colleagues find the process as a way to increase the patient “pass through.” Many patients presume that the APRN is a reasonable alternative to a busy cardiologist or are interacting with their cardiologist.
As doctors, we are divesting ourselves from the one thing that sets us apart and makes us unique in the health care system; the ability to interact with patients in a comprehensive way. We seem to be on the slippery slope to medical obsolescence, soon to be replaced by staff who can triage our patients to the next appropriate test. Both the patient and doctor seem to have slipped into a Walmart-like world where expedience dominates over skill and shortcuts are the alternative to thoughtful personal physician-patient interaction.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
In case you didn’t notice, our clinical practice has been reinforced by a entirely new class of performers who have become essential to our daily activities.
They are Advanced Practice Registered Nurses, whose role has evolved over the last 50 years from the Coronary Care Unit nurse with special training in coronary care to an array of well-trained women and men who have received both Bachelor’s and Master’s degrees in Nursing.
As a further extension of their training, many are now going on to achieve a further doctorate degree in nursing after 90 hours of postgraduate classes at certified academic centers and additional clinical experience in a variety of fields, including cardiology. The nurses completing those programs will be certified and licensed as APRNs. They come to our practice with remarkable experience and expertise in arrhythmia and heart failure management, as well as interventional skills, on top of wide experience in the management of patients in critical care units. Their integration into comprehensive and collaborative cardiac care raises challenges to and opportunities for the cardiologist.
A recent survey of large cardiology clinics initiated by the Summit Medical Group assessed the role of the APRN in the care of patients both in hospitals and in clinics. It reported that in many of cardiology clinics surveyed, APRNs provide an expanding role in patient care leading to variable relationships between the patient and the cardiologist. In some settings, the APRNs often function independent of physician interaction, initiating the patients’ entrance into the clinic and managing their follow-up. In other situations, they may be supervised by a cardiologist and their future laboratory studies and therapy are completely managed by the APRN, who functions as a professional associate of a physician. However, in many situations the cardiologist may have little or no contact with the patient.
While the APRN is seeing the patient, the cardiologists often are seeing their own patients or, more likely, are involved with maintaining the electronic medical record or performing or interpreting tests that are usually reimbursed at a fee that is a multiple of that received for a patient visit alone. Much of this is carried out under the heading of “coordinated care” and is managed in a multidisciplinary matrix in which many specialists and APRNs play a role in the care of the patient. In this setting, the doctor has become manager of a diverse group of support staff, including APRNs, and may be increasingly remote from direct patient care. My medical colleagues find the process as a way to increase the patient “pass through.” Many patients presume that the APRN is a reasonable alternative to a busy cardiologist or are interacting with their cardiologist.
As doctors, we are divesting ourselves from the one thing that sets us apart and makes us unique in the health care system; the ability to interact with patients in a comprehensive way. We seem to be on the slippery slope to medical obsolescence, soon to be replaced by staff who can triage our patients to the next appropriate test. Both the patient and doctor seem to have slipped into a Walmart-like world where expedience dominates over skill and shortcuts are the alternative to thoughtful personal physician-patient interaction.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
VIDEO: Winning health apps link patients, researchers
SANTA CLARA, CALIF. – The federal Patient-Centered Outcomes Research Institute picked three apps for $150,000 in award funding to help patients and researchers connect and collaborate.
The Institute’s Dr. Karen Odom Walker moderated a Hospital Innovation Roundtable session at the Health 2.0 fall conference. In a video interview at the meeting, she described the work of the Patient-Centered Outcomes Research Institute (PCORI), which was part of the Affordable Care Act and is based in Washington, D.C.
So far, PCORI has awarded more than $500 million to 300 projects for patient-centered research, and it plans to distribute another $3.5 billion by 2019, she said.
The winners of PCORI’s 2014 Matchmaking App Challenge, announced at the conference, developed ready-to-use Web-based or smartphone apps to link patients, caregivers, clinicians, and researchers in various ways.
First-place winner PatientPowered.us of San Francisco received $100,000 for its mobile network connecting patients with researchers and healthcare professionals to share ideas for solving their medical conditions, such as Crohn’s disease, sleep apnea, migraines, or others, and to connect patients with clinical trials.
Second-place winner WellSpringboard, from the University of Michigan, Ann Arbor, received $35,000 for its software platform to enable crowdfunding of patient-focused research. CareHubs of Beaverton, Ore. received $15,000 in third-place prize money for a platform for patient engagement in health systems.
Dr. Walker’s spouse works for MedImmune. She reported having no other financial disclosures.
On Twitter @sherryboschert
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SANTA CLARA, CALIF. – The federal Patient-Centered Outcomes Research Institute picked three apps for $150,000 in award funding to help patients and researchers connect and collaborate.
The Institute’s Dr. Karen Odom Walker moderated a Hospital Innovation Roundtable session at the Health 2.0 fall conference. In a video interview at the meeting, she described the work of the Patient-Centered Outcomes Research Institute (PCORI), which was part of the Affordable Care Act and is based in Washington, D.C.
So far, PCORI has awarded more than $500 million to 300 projects for patient-centered research, and it plans to distribute another $3.5 billion by 2019, she said.
The winners of PCORI’s 2014 Matchmaking App Challenge, announced at the conference, developed ready-to-use Web-based or smartphone apps to link patients, caregivers, clinicians, and researchers in various ways.
First-place winner PatientPowered.us of San Francisco received $100,000 for its mobile network connecting patients with researchers and healthcare professionals to share ideas for solving their medical conditions, such as Crohn’s disease, sleep apnea, migraines, or others, and to connect patients with clinical trials.
Second-place winner WellSpringboard, from the University of Michigan, Ann Arbor, received $35,000 for its software platform to enable crowdfunding of patient-focused research. CareHubs of Beaverton, Ore. received $15,000 in third-place prize money for a platform for patient engagement in health systems.
Dr. Walker’s spouse works for MedImmune. She reported having no other financial disclosures.
On Twitter @sherryboschert
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SANTA CLARA, CALIF. – The federal Patient-Centered Outcomes Research Institute picked three apps for $150,000 in award funding to help patients and researchers connect and collaborate.
The Institute’s Dr. Karen Odom Walker moderated a Hospital Innovation Roundtable session at the Health 2.0 fall conference. In a video interview at the meeting, she described the work of the Patient-Centered Outcomes Research Institute (PCORI), which was part of the Affordable Care Act and is based in Washington, D.C.
So far, PCORI has awarded more than $500 million to 300 projects for patient-centered research, and it plans to distribute another $3.5 billion by 2019, she said.
The winners of PCORI’s 2014 Matchmaking App Challenge, announced at the conference, developed ready-to-use Web-based or smartphone apps to link patients, caregivers, clinicians, and researchers in various ways.
First-place winner PatientPowered.us of San Francisco received $100,000 for its mobile network connecting patients with researchers and healthcare professionals to share ideas for solving their medical conditions, such as Crohn’s disease, sleep apnea, migraines, or others, and to connect patients with clinical trials.
Second-place winner WellSpringboard, from the University of Michigan, Ann Arbor, received $35,000 for its software platform to enable crowdfunding of patient-focused research. CareHubs of Beaverton, Ore. received $15,000 in third-place prize money for a platform for patient engagement in health systems.
Dr. Walker’s spouse works for MedImmune. She reported having no other financial disclosures.
On Twitter @sherryboschert
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE HEALTH 2.0 FALL CONFERENCE 2014
VIDEO: Software platform may improve care efficiency
SANTA CLARA, CALIF. – Electronic health records are everywhere, but how can a health system best use all the data that it collects?
Software platforms are emerging to organize and analyze the data for population health management. One new system from the company Acupera has been implemented in St. Vincent Health, an 18-hospital system in Indiana that’s part of Ascension Health, based in St. Louis.
The computerized platform led to a sixfold improvement in the efficiency of care managers, increasing their case loads from 14 patients to more than 85 patients per week, says Dr. Ronald Razmi, a former cardiologist who founded and serves as chief executive officer of San Francisco-based Acupera.
In a video interview at the Health 2.0 fall conference 2014, he described the platform, how it works, and how it could improve health outcomes.
On Twitter @sherryboschert
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SANTA CLARA, CALIF. – Electronic health records are everywhere, but how can a health system best use all the data that it collects?
Software platforms are emerging to organize and analyze the data for population health management. One new system from the company Acupera has been implemented in St. Vincent Health, an 18-hospital system in Indiana that’s part of Ascension Health, based in St. Louis.
The computerized platform led to a sixfold improvement in the efficiency of care managers, increasing their case loads from 14 patients to more than 85 patients per week, says Dr. Ronald Razmi, a former cardiologist who founded and serves as chief executive officer of San Francisco-based Acupera.
In a video interview at the Health 2.0 fall conference 2014, he described the platform, how it works, and how it could improve health outcomes.
On Twitter @sherryboschert
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SANTA CLARA, CALIF. – Electronic health records are everywhere, but how can a health system best use all the data that it collects?
Software platforms are emerging to organize and analyze the data for population health management. One new system from the company Acupera has been implemented in St. Vincent Health, an 18-hospital system in Indiana that’s part of Ascension Health, based in St. Louis.
The computerized platform led to a sixfold improvement in the efficiency of care managers, increasing their case loads from 14 patients to more than 85 patients per week, says Dr. Ronald Razmi, a former cardiologist who founded and serves as chief executive officer of San Francisco-based Acupera.
In a video interview at the Health 2.0 fall conference 2014, he described the platform, how it works, and how it could improve health outcomes.
On Twitter @sherryboschert
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE HEALTH 2.0 FALL CONFERENCE 2014
Should ductal carcinoma in situ be treated?
Remarks given during a session of the ASCO Breast Cancer Symposium titled Ductal Carcinoma in Situ Debate: Treatment vs. Observation
Dr. Kuerer comments: There has been a marked increase ductal carcinoma in situ (DCIS) in what is being called overdiagnosis, and this is leading to concerns of overtreatment, which has been in the news now for several years. We have more than 60,000 cases of DCIS diagnosed per year in the United States. We’re trying to prevent invasive breast cancer and distant metastases. The problem is identifying which patients will go on to develop invasive disease. That’s really unknown.
At M.D. Anderson, looking at 10-year follow-up of 2,449 patients, the rate of developing distant metastases was 0.1%. The problem with this is that no prominent variables were associated with the development of invasive metastatic disease. Overall, we are doing a good job at preventing death from breast cancer when we treat DCIS, with less than 1% of patients dying of breast cancer (Ann. Surg. Onc. 2011;18:2873-8).
Dr. Shelley E. Hwang and her group very elegantly started exploring preoperative systemic therapy as a way to get a clue about which patients might be safely observed alone (that is, a core biopsy diagnosis of DCIS and then just follow-up without surgery or other treatments). At M.D. Anderson, we studied whether or not we could eradicate DCIS in patients with human epidermal growth factor receptor 2 (HER2) overexpression by treatment with trastuzumab prior to surgery, under the hypothesis that if we could eradicate the DCIS, we might eventually use this drug potentially to prevent HER2-positive invasive breast cancers. We saw very dramatic responses in their immune response with antibody-dependent cellular cytotoxicity mediated by natural killer cells, which is exciting, but there were no histopathologic changes. The most important finding was that 42% of our patients who we thought only had DCIS actually had occult invasive breast cancer (Cancer 2011;117:39-47). This is concerning because without surgery, we may be missing or leaving untreated invasive breast cancers in some patients.
So, we have an underestimation of invasive breast cancer at DCIS diagnosis. A very elegant meta-analysis of 7,350 patients reported that even if we take patients with non–high-grade, very-small DCIS, we’re still looking at an upgrade to invasive cancer of about 20% (Radiology 2011;260:119-28). The best and most recent studies of MRI and DCIS again found a diagnostic upgrade of about 27%. There were no MRI features correlating with invasive breast cancer, and this resulted in a 31% increase in procedures and more biopsies with the use of MRI.
So where are we? In active surveillance of 14 patients with DCIS at the University of California, San Francisco, 8 went on to surgery at a median follow-up of 28 months, and 5 of the 8 (62%) had invasive breast cancer (The Breast 2011;20:529-33).
What’s the cost to the health care system of surveillance if we biopsy only the DCIS and follow it without surgery or other adjuvant therapies? The psychological cost to our patients? What is the natural history of DCIS if left in place? What will be the result of microcalcifications? How are we going to follow this? What are the criteria that we will use for repeat biopsy? This really is not known.
Which are the patients that we’re going to select for observation alone? There are trials in Europe that have begun or will begin to address the safety of just observing DCIS without surgery and other therapies.
The United Kingdom Low-Risk DCIS Trial is randomizing patients with low and intermediate grade DCIS of any size to biopsy alone without surgical intervention (active monitoring) or standard therapy. Another trial, a joint Dutch Breast Cancer Research Group and European Organization for the Research and Treatment of Cancer trial is randomizing women with low-risk, low-grade DCIS to active surveillance or standard treatment. If we look at M.D. Anderson’s data and our National Cancer Database, only about 10%-15% of patients would be eligible for the latter study. I don’t think with these numbers we’d have a great impact, but it is a start.
I submit that the best U.S. patients to study will be patients with a diagnosis of atypical ductal hyperplasia (generally the smallest lesions and perhaps the earliest form of DCIS) because we have about 100,000 cases each year.
What’s the patient’s perspective? What about the need for continued repeat biopsies, and how this will affect their overall quality of life? Do patients in the United States really want to observe the DCIS in an era when our patients are requesting more and more mastectomy with reconstruction and contralateral mastectomy at diagnosis of DCIS? I seriously doubt that our patients in the United States would agree to be randomized in DCIS trials to no treatment at all. I really don’t know.
Dr. Kuerer is a professor of surgery at the University of Texas M.D. Anderson Cancer Center, Houston. He reported financial associations with Gerson Lehrman Group and McGraw-Hill Publishing.
Dr. Hwang comments: Today, about 1/1,300 screening mammograms result in a diagnosis of DCIS. There are two important considerations when we talk about active surveillance or doing less aggressive treatment. First, what is the rate at which progression to invasive cancer can occur, either with or without treatment? Second, what is the fate of these DCIS lesions? These are issues for which we currently don’t have good answers.
We’re treating all disease detected at an early stage, and for the sake of argument, I’ll include DCIS, as if it likely will cause harm if we did absolutely nothing when, in fact, there could be many cancers that progress so slowly and have such a low propensity for developing metastatic disease that they would not likely cause any symptoms or harm during a patient’s lifetime.
In autopsy series, the disease reservoir of unrecognized DCIS is about 9% and the disease reservoir of invasive cancer is about 1%. It’s not that different from prostate cancer, although at a much lower rate. These data show that there certainly are women who die with DCIS rather than of it.
We really don’t have a very solid understanding of the natural history of DCIS. If we do nothing, but maybe surgically biopsy it, what happens to these patients in the long term? In a meta-analysis, the world’s literature included only 151 cases of women who had surgical biopsy of DCIS that initially was misdiagnosed as a benign lesion and therefore didn’t undergo any further therapy, some with up to 31 years of follow-up. The long-term risk of invasive cancer in this cohort is only 22% (Breast Cancer Res. Treat. 2006;97:135-44). The annual risk of breast cancer in women with atypia is 1% per year, so this ends up looking very similar to the risk of progression that you see for atypical ductal hyperplasia or lobular carcinoma in situ.
The most common treatment for DCIS in the United States is lumpectomy with radiation. A meta-analysis by the European Breast Cancer Trialists’ Group found a 50% proportional reduction in local recurrence risk in women treated with lumpectomy and radiation vs. lumpectomy alone. The absolute magnitude of reduction was dependent on baseline recurrence risk. That’s a really important concept, because if your baseline risk is only 5%, then the 50% proportional reduction only translates into a 2.5% reduction in risk in 10 years.
The prospective, randomized Radiation Therapy Oncologists Group 9804 study randomized low-risk women with DCIS, unlike prior randomized trials that included broad eligibility criteria for DCIS. In 5 years of follow-up, the ipsilateral recurrence risk (which includes both invasive cancer and DCIS) was 3.2% in the lumpectomy-only group vs. 0.4% in the lumpectomy and radiation therapy group. The difference is highly statistically significant, however, given the small absolute difference between groups, the clinical significance certainly can be argued. There was no significant difference between groups in contralateral new primary lesions (Radiat. Oncol. 2012;84:S5).
We just presented a study this year looking at DCIS and competing causes of mortality in different age groups with different types of treatment. Among women with DCIS over 70 years of age, there was a significant difference in overall survival but none of the treatments conferred any benefit in disease-specific survival.
Active surveillance alone may be reasonable to consider in some patients. We can learn a lot from our colleagues who treat prostate cancer. They’re at least 10 years ahead of us in thinking about reducing the harms that have been introduced by screening for prostate cancer. When you look at breast cancer–specific and other-cause mortality in the setting of DCIS, the mortality curves look very similar to those with early-stage prostate cancer. Women with DCIS, regardless of what they are treated with, die of other causes and very rarely die of breast cancer.
When we compare such different options as mastectomy to active surveillance only, it’s really hard for a patient to feel that both of those approaches can offer them the same outcomes. But when you look at the actual data and evidence, the differences in recurrence or progression to invasive cancer don’t translate easily into a large difference in breast cancer mortality provided that patients are diagnosed at stage I or II, with more than a 90% survival from breast cancer.
We have an opportunity to take a big step back and redefine our goals of DCIS “treatment” from “curing” DCIS to trying to reduce breast cancer-specific mortality. This will help us reduce the harms that can result from screening and will reserve our aggressive treatments for those most likely to benefit from them.
Dr. Hwang is a professor of surgery at Duke University, Durham, N.C. She serves as a consultant for Genomic Health.
Remarks given during a session of the ASCO Breast Cancer Symposium titled Ductal Carcinoma in Situ Debate: Treatment vs. Observation
Dr. Kuerer comments: There has been a marked increase ductal carcinoma in situ (DCIS) in what is being called overdiagnosis, and this is leading to concerns of overtreatment, which has been in the news now for several years. We have more than 60,000 cases of DCIS diagnosed per year in the United States. We’re trying to prevent invasive breast cancer and distant metastases. The problem is identifying which patients will go on to develop invasive disease. That’s really unknown.
At M.D. Anderson, looking at 10-year follow-up of 2,449 patients, the rate of developing distant metastases was 0.1%. The problem with this is that no prominent variables were associated with the development of invasive metastatic disease. Overall, we are doing a good job at preventing death from breast cancer when we treat DCIS, with less than 1% of patients dying of breast cancer (Ann. Surg. Onc. 2011;18:2873-8).
Dr. Shelley E. Hwang and her group very elegantly started exploring preoperative systemic therapy as a way to get a clue about which patients might be safely observed alone (that is, a core biopsy diagnosis of DCIS and then just follow-up without surgery or other treatments). At M.D. Anderson, we studied whether or not we could eradicate DCIS in patients with human epidermal growth factor receptor 2 (HER2) overexpression by treatment with trastuzumab prior to surgery, under the hypothesis that if we could eradicate the DCIS, we might eventually use this drug potentially to prevent HER2-positive invasive breast cancers. We saw very dramatic responses in their immune response with antibody-dependent cellular cytotoxicity mediated by natural killer cells, which is exciting, but there were no histopathologic changes. The most important finding was that 42% of our patients who we thought only had DCIS actually had occult invasive breast cancer (Cancer 2011;117:39-47). This is concerning because without surgery, we may be missing or leaving untreated invasive breast cancers in some patients.
So, we have an underestimation of invasive breast cancer at DCIS diagnosis. A very elegant meta-analysis of 7,350 patients reported that even if we take patients with non–high-grade, very-small DCIS, we’re still looking at an upgrade to invasive cancer of about 20% (Radiology 2011;260:119-28). The best and most recent studies of MRI and DCIS again found a diagnostic upgrade of about 27%. There were no MRI features correlating with invasive breast cancer, and this resulted in a 31% increase in procedures and more biopsies with the use of MRI.
So where are we? In active surveillance of 14 patients with DCIS at the University of California, San Francisco, 8 went on to surgery at a median follow-up of 28 months, and 5 of the 8 (62%) had invasive breast cancer (The Breast 2011;20:529-33).
What’s the cost to the health care system of surveillance if we biopsy only the DCIS and follow it without surgery or other adjuvant therapies? The psychological cost to our patients? What is the natural history of DCIS if left in place? What will be the result of microcalcifications? How are we going to follow this? What are the criteria that we will use for repeat biopsy? This really is not known.
Which are the patients that we’re going to select for observation alone? There are trials in Europe that have begun or will begin to address the safety of just observing DCIS without surgery and other therapies.
The United Kingdom Low-Risk DCIS Trial is randomizing patients with low and intermediate grade DCIS of any size to biopsy alone without surgical intervention (active monitoring) or standard therapy. Another trial, a joint Dutch Breast Cancer Research Group and European Organization for the Research and Treatment of Cancer trial is randomizing women with low-risk, low-grade DCIS to active surveillance or standard treatment. If we look at M.D. Anderson’s data and our National Cancer Database, only about 10%-15% of patients would be eligible for the latter study. I don’t think with these numbers we’d have a great impact, but it is a start.
I submit that the best U.S. patients to study will be patients with a diagnosis of atypical ductal hyperplasia (generally the smallest lesions and perhaps the earliest form of DCIS) because we have about 100,000 cases each year.
What’s the patient’s perspective? What about the need for continued repeat biopsies, and how this will affect their overall quality of life? Do patients in the United States really want to observe the DCIS in an era when our patients are requesting more and more mastectomy with reconstruction and contralateral mastectomy at diagnosis of DCIS? I seriously doubt that our patients in the United States would agree to be randomized in DCIS trials to no treatment at all. I really don’t know.
Dr. Kuerer is a professor of surgery at the University of Texas M.D. Anderson Cancer Center, Houston. He reported financial associations with Gerson Lehrman Group and McGraw-Hill Publishing.
Dr. Hwang comments: Today, about 1/1,300 screening mammograms result in a diagnosis of DCIS. There are two important considerations when we talk about active surveillance or doing less aggressive treatment. First, what is the rate at which progression to invasive cancer can occur, either with or without treatment? Second, what is the fate of these DCIS lesions? These are issues for which we currently don’t have good answers.
We’re treating all disease detected at an early stage, and for the sake of argument, I’ll include DCIS, as if it likely will cause harm if we did absolutely nothing when, in fact, there could be many cancers that progress so slowly and have such a low propensity for developing metastatic disease that they would not likely cause any symptoms or harm during a patient’s lifetime.
In autopsy series, the disease reservoir of unrecognized DCIS is about 9% and the disease reservoir of invasive cancer is about 1%. It’s not that different from prostate cancer, although at a much lower rate. These data show that there certainly are women who die with DCIS rather than of it.
We really don’t have a very solid understanding of the natural history of DCIS. If we do nothing, but maybe surgically biopsy it, what happens to these patients in the long term? In a meta-analysis, the world’s literature included only 151 cases of women who had surgical biopsy of DCIS that initially was misdiagnosed as a benign lesion and therefore didn’t undergo any further therapy, some with up to 31 years of follow-up. The long-term risk of invasive cancer in this cohort is only 22% (Breast Cancer Res. Treat. 2006;97:135-44). The annual risk of breast cancer in women with atypia is 1% per year, so this ends up looking very similar to the risk of progression that you see for atypical ductal hyperplasia or lobular carcinoma in situ.
The most common treatment for DCIS in the United States is lumpectomy with radiation. A meta-analysis by the European Breast Cancer Trialists’ Group found a 50% proportional reduction in local recurrence risk in women treated with lumpectomy and radiation vs. lumpectomy alone. The absolute magnitude of reduction was dependent on baseline recurrence risk. That’s a really important concept, because if your baseline risk is only 5%, then the 50% proportional reduction only translates into a 2.5% reduction in risk in 10 years.
The prospective, randomized Radiation Therapy Oncologists Group 9804 study randomized low-risk women with DCIS, unlike prior randomized trials that included broad eligibility criteria for DCIS. In 5 years of follow-up, the ipsilateral recurrence risk (which includes both invasive cancer and DCIS) was 3.2% in the lumpectomy-only group vs. 0.4% in the lumpectomy and radiation therapy group. The difference is highly statistically significant, however, given the small absolute difference between groups, the clinical significance certainly can be argued. There was no significant difference between groups in contralateral new primary lesions (Radiat. Oncol. 2012;84:S5).
We just presented a study this year looking at DCIS and competing causes of mortality in different age groups with different types of treatment. Among women with DCIS over 70 years of age, there was a significant difference in overall survival but none of the treatments conferred any benefit in disease-specific survival.
Active surveillance alone may be reasonable to consider in some patients. We can learn a lot from our colleagues who treat prostate cancer. They’re at least 10 years ahead of us in thinking about reducing the harms that have been introduced by screening for prostate cancer. When you look at breast cancer–specific and other-cause mortality in the setting of DCIS, the mortality curves look very similar to those with early-stage prostate cancer. Women with DCIS, regardless of what they are treated with, die of other causes and very rarely die of breast cancer.
When we compare such different options as mastectomy to active surveillance only, it’s really hard for a patient to feel that both of those approaches can offer them the same outcomes. But when you look at the actual data and evidence, the differences in recurrence or progression to invasive cancer don’t translate easily into a large difference in breast cancer mortality provided that patients are diagnosed at stage I or II, with more than a 90% survival from breast cancer.
We have an opportunity to take a big step back and redefine our goals of DCIS “treatment” from “curing” DCIS to trying to reduce breast cancer-specific mortality. This will help us reduce the harms that can result from screening and will reserve our aggressive treatments for those most likely to benefit from them.
Dr. Hwang is a professor of surgery at Duke University, Durham, N.C. She serves as a consultant for Genomic Health.
Remarks given during a session of the ASCO Breast Cancer Symposium titled Ductal Carcinoma in Situ Debate: Treatment vs. Observation
Dr. Kuerer comments: There has been a marked increase ductal carcinoma in situ (DCIS) in what is being called overdiagnosis, and this is leading to concerns of overtreatment, which has been in the news now for several years. We have more than 60,000 cases of DCIS diagnosed per year in the United States. We’re trying to prevent invasive breast cancer and distant metastases. The problem is identifying which patients will go on to develop invasive disease. That’s really unknown.
At M.D. Anderson, looking at 10-year follow-up of 2,449 patients, the rate of developing distant metastases was 0.1%. The problem with this is that no prominent variables were associated with the development of invasive metastatic disease. Overall, we are doing a good job at preventing death from breast cancer when we treat DCIS, with less than 1% of patients dying of breast cancer (Ann. Surg. Onc. 2011;18:2873-8).
Dr. Shelley E. Hwang and her group very elegantly started exploring preoperative systemic therapy as a way to get a clue about which patients might be safely observed alone (that is, a core biopsy diagnosis of DCIS and then just follow-up without surgery or other treatments). At M.D. Anderson, we studied whether or not we could eradicate DCIS in patients with human epidermal growth factor receptor 2 (HER2) overexpression by treatment with trastuzumab prior to surgery, under the hypothesis that if we could eradicate the DCIS, we might eventually use this drug potentially to prevent HER2-positive invasive breast cancers. We saw very dramatic responses in their immune response with antibody-dependent cellular cytotoxicity mediated by natural killer cells, which is exciting, but there were no histopathologic changes. The most important finding was that 42% of our patients who we thought only had DCIS actually had occult invasive breast cancer (Cancer 2011;117:39-47). This is concerning because without surgery, we may be missing or leaving untreated invasive breast cancers in some patients.
So, we have an underestimation of invasive breast cancer at DCIS diagnosis. A very elegant meta-analysis of 7,350 patients reported that even if we take patients with non–high-grade, very-small DCIS, we’re still looking at an upgrade to invasive cancer of about 20% (Radiology 2011;260:119-28). The best and most recent studies of MRI and DCIS again found a diagnostic upgrade of about 27%. There were no MRI features correlating with invasive breast cancer, and this resulted in a 31% increase in procedures and more biopsies with the use of MRI.
So where are we? In active surveillance of 14 patients with DCIS at the University of California, San Francisco, 8 went on to surgery at a median follow-up of 28 months, and 5 of the 8 (62%) had invasive breast cancer (The Breast 2011;20:529-33).
What’s the cost to the health care system of surveillance if we biopsy only the DCIS and follow it without surgery or other adjuvant therapies? The psychological cost to our patients? What is the natural history of DCIS if left in place? What will be the result of microcalcifications? How are we going to follow this? What are the criteria that we will use for repeat biopsy? This really is not known.
Which are the patients that we’re going to select for observation alone? There are trials in Europe that have begun or will begin to address the safety of just observing DCIS without surgery and other therapies.
The United Kingdom Low-Risk DCIS Trial is randomizing patients with low and intermediate grade DCIS of any size to biopsy alone without surgical intervention (active monitoring) or standard therapy. Another trial, a joint Dutch Breast Cancer Research Group and European Organization for the Research and Treatment of Cancer trial is randomizing women with low-risk, low-grade DCIS to active surveillance or standard treatment. If we look at M.D. Anderson’s data and our National Cancer Database, only about 10%-15% of patients would be eligible for the latter study. I don’t think with these numbers we’d have a great impact, but it is a start.
I submit that the best U.S. patients to study will be patients with a diagnosis of atypical ductal hyperplasia (generally the smallest lesions and perhaps the earliest form of DCIS) because we have about 100,000 cases each year.
What’s the patient’s perspective? What about the need for continued repeat biopsies, and how this will affect their overall quality of life? Do patients in the United States really want to observe the DCIS in an era when our patients are requesting more and more mastectomy with reconstruction and contralateral mastectomy at diagnosis of DCIS? I seriously doubt that our patients in the United States would agree to be randomized in DCIS trials to no treatment at all. I really don’t know.
Dr. Kuerer is a professor of surgery at the University of Texas M.D. Anderson Cancer Center, Houston. He reported financial associations with Gerson Lehrman Group and McGraw-Hill Publishing.
Dr. Hwang comments: Today, about 1/1,300 screening mammograms result in a diagnosis of DCIS. There are two important considerations when we talk about active surveillance or doing less aggressive treatment. First, what is the rate at which progression to invasive cancer can occur, either with or without treatment? Second, what is the fate of these DCIS lesions? These are issues for which we currently don’t have good answers.
We’re treating all disease detected at an early stage, and for the sake of argument, I’ll include DCIS, as if it likely will cause harm if we did absolutely nothing when, in fact, there could be many cancers that progress so slowly and have such a low propensity for developing metastatic disease that they would not likely cause any symptoms or harm during a patient’s lifetime.
In autopsy series, the disease reservoir of unrecognized DCIS is about 9% and the disease reservoir of invasive cancer is about 1%. It’s not that different from prostate cancer, although at a much lower rate. These data show that there certainly are women who die with DCIS rather than of it.
We really don’t have a very solid understanding of the natural history of DCIS. If we do nothing, but maybe surgically biopsy it, what happens to these patients in the long term? In a meta-analysis, the world’s literature included only 151 cases of women who had surgical biopsy of DCIS that initially was misdiagnosed as a benign lesion and therefore didn’t undergo any further therapy, some with up to 31 years of follow-up. The long-term risk of invasive cancer in this cohort is only 22% (Breast Cancer Res. Treat. 2006;97:135-44). The annual risk of breast cancer in women with atypia is 1% per year, so this ends up looking very similar to the risk of progression that you see for atypical ductal hyperplasia or lobular carcinoma in situ.
The most common treatment for DCIS in the United States is lumpectomy with radiation. A meta-analysis by the European Breast Cancer Trialists’ Group found a 50% proportional reduction in local recurrence risk in women treated with lumpectomy and radiation vs. lumpectomy alone. The absolute magnitude of reduction was dependent on baseline recurrence risk. That’s a really important concept, because if your baseline risk is only 5%, then the 50% proportional reduction only translates into a 2.5% reduction in risk in 10 years.
The prospective, randomized Radiation Therapy Oncologists Group 9804 study randomized low-risk women with DCIS, unlike prior randomized trials that included broad eligibility criteria for DCIS. In 5 years of follow-up, the ipsilateral recurrence risk (which includes both invasive cancer and DCIS) was 3.2% in the lumpectomy-only group vs. 0.4% in the lumpectomy and radiation therapy group. The difference is highly statistically significant, however, given the small absolute difference between groups, the clinical significance certainly can be argued. There was no significant difference between groups in contralateral new primary lesions (Radiat. Oncol. 2012;84:S5).
We just presented a study this year looking at DCIS and competing causes of mortality in different age groups with different types of treatment. Among women with DCIS over 70 years of age, there was a significant difference in overall survival but none of the treatments conferred any benefit in disease-specific survival.
Active surveillance alone may be reasonable to consider in some patients. We can learn a lot from our colleagues who treat prostate cancer. They’re at least 10 years ahead of us in thinking about reducing the harms that have been introduced by screening for prostate cancer. When you look at breast cancer–specific and other-cause mortality in the setting of DCIS, the mortality curves look very similar to those with early-stage prostate cancer. Women with DCIS, regardless of what they are treated with, die of other causes and very rarely die of breast cancer.
When we compare such different options as mastectomy to active surveillance only, it’s really hard for a patient to feel that both of those approaches can offer them the same outcomes. But when you look at the actual data and evidence, the differences in recurrence or progression to invasive cancer don’t translate easily into a large difference in breast cancer mortality provided that patients are diagnosed at stage I or II, with more than a 90% survival from breast cancer.
We have an opportunity to take a big step back and redefine our goals of DCIS “treatment” from “curing” DCIS to trying to reduce breast cancer-specific mortality. This will help us reduce the harms that can result from screening and will reserve our aggressive treatments for those most likely to benefit from them.
Dr. Hwang is a professor of surgery at Duke University, Durham, N.C. She serves as a consultant for Genomic Health.
Promoting recovery for patients with schizophrenia
This year’s theme for World Mental Health Day, “living with schizophrenia,” is a valuable message for those of us who treat patients with the illness and for the patients themselves.
After all, about 25% of people with schizophrenia reportedly recover fully, and 25%-35% improve considerably. This means that with effective treatment and interventions, up to 50% of people with schizophrenia can live productive and satisfying lives (Schizophr. Bull 2006;32:432-42).
The medications, awareness, and research needed to make schizophrenia a manageable disease must be combined with a supportive network for the patient. In addition, compliance in terms of strict adherence to medications is needed to keep the illness at bay, as are employment, nutrition, physical well-being, and avoidance of substance abuse.
Authors of the World Federation for Mental Health’s report on World Mental Health Day 2014 cited two examples of the kinds of services that can help patients with schizophrenia lead productive lives. Fountain House, a professional self-help program based in New York, assists people living with mental illness with securing jobs, schooling, housing, and wellness. Some suggest that these kinds of recovery centers might be an “emerging best practice” (Psychiatric Serv. 2012 [doi:10.1176/appi.ps.201200p10]).
The other example of a model cited by the authors describes the chain-free initiative in Mogadishu, Somalia. This model includes three phases. In phase 1, chains are literally removed from patients; in phase 2, professionals visit patients at home and provide family psychosocial education; and in phase 3, the focus is on “removing the ‘invisible chains’ of stigma and restrictions affecting the human rights of persons with mental illness.” Thanks to this initiative, more former patients reportedly are living in the community, and the community has greater awareness about the rights of people with severe mental illness.
Reducing stigma is critical, as this factor has the capacity to determine the prognosis of schizophrenia. Let’s toss out terms describing people with schizophrenia such as “crazy,” “dangerous,” “not manageable at home,” “unemployable,” and “unable to function in society.”
In 2012, the 5th Geneva Conference on Person-Centered Medicine made several recommendations that incorporate many of the principles promoted by Fountain House and the chain-free initiative. They include integrating health promotion and illness prevention; engaging health services in prevention, diagnosis, and treatment of diseases through multidisciplinary approaches; collaborating closely on clinical care and public health; engaging civil society in such efforts.
Health care workers across the globe face big challenges when it comes to managing schizophrenia. Those of us practicing medicine in developing and developed countries must educate, raise awareness, and mobilize resources in the fight against the illness.
Schizophrenia remains a major global mental health problem, but living with the illness has become possible. Perhaps 10 to 20 years down the road, we will be closer to identifying a cause, and this discovery, in turn, might lead to new horizons for treatment.
Dr. Gadit is a professor of psychiatry at the University of Toronto.
This year’s theme for World Mental Health Day, “living with schizophrenia,” is a valuable message for those of us who treat patients with the illness and for the patients themselves.
After all, about 25% of people with schizophrenia reportedly recover fully, and 25%-35% improve considerably. This means that with effective treatment and interventions, up to 50% of people with schizophrenia can live productive and satisfying lives (Schizophr. Bull 2006;32:432-42).
The medications, awareness, and research needed to make schizophrenia a manageable disease must be combined with a supportive network for the patient. In addition, compliance in terms of strict adherence to medications is needed to keep the illness at bay, as are employment, nutrition, physical well-being, and avoidance of substance abuse.
Authors of the World Federation for Mental Health’s report on World Mental Health Day 2014 cited two examples of the kinds of services that can help patients with schizophrenia lead productive lives. Fountain House, a professional self-help program based in New York, assists people living with mental illness with securing jobs, schooling, housing, and wellness. Some suggest that these kinds of recovery centers might be an “emerging best practice” (Psychiatric Serv. 2012 [doi:10.1176/appi.ps.201200p10]).
The other example of a model cited by the authors describes the chain-free initiative in Mogadishu, Somalia. This model includes three phases. In phase 1, chains are literally removed from patients; in phase 2, professionals visit patients at home and provide family psychosocial education; and in phase 3, the focus is on “removing the ‘invisible chains’ of stigma and restrictions affecting the human rights of persons with mental illness.” Thanks to this initiative, more former patients reportedly are living in the community, and the community has greater awareness about the rights of people with severe mental illness.
Reducing stigma is critical, as this factor has the capacity to determine the prognosis of schizophrenia. Let’s toss out terms describing people with schizophrenia such as “crazy,” “dangerous,” “not manageable at home,” “unemployable,” and “unable to function in society.”
In 2012, the 5th Geneva Conference on Person-Centered Medicine made several recommendations that incorporate many of the principles promoted by Fountain House and the chain-free initiative. They include integrating health promotion and illness prevention; engaging health services in prevention, diagnosis, and treatment of diseases through multidisciplinary approaches; collaborating closely on clinical care and public health; engaging civil society in such efforts.
Health care workers across the globe face big challenges when it comes to managing schizophrenia. Those of us practicing medicine in developing and developed countries must educate, raise awareness, and mobilize resources in the fight against the illness.
Schizophrenia remains a major global mental health problem, but living with the illness has become possible. Perhaps 10 to 20 years down the road, we will be closer to identifying a cause, and this discovery, in turn, might lead to new horizons for treatment.
Dr. Gadit is a professor of psychiatry at the University of Toronto.
This year’s theme for World Mental Health Day, “living with schizophrenia,” is a valuable message for those of us who treat patients with the illness and for the patients themselves.
After all, about 25% of people with schizophrenia reportedly recover fully, and 25%-35% improve considerably. This means that with effective treatment and interventions, up to 50% of people with schizophrenia can live productive and satisfying lives (Schizophr. Bull 2006;32:432-42).
The medications, awareness, and research needed to make schizophrenia a manageable disease must be combined with a supportive network for the patient. In addition, compliance in terms of strict adherence to medications is needed to keep the illness at bay, as are employment, nutrition, physical well-being, and avoidance of substance abuse.
Authors of the World Federation for Mental Health’s report on World Mental Health Day 2014 cited two examples of the kinds of services that can help patients with schizophrenia lead productive lives. Fountain House, a professional self-help program based in New York, assists people living with mental illness with securing jobs, schooling, housing, and wellness. Some suggest that these kinds of recovery centers might be an “emerging best practice” (Psychiatric Serv. 2012 [doi:10.1176/appi.ps.201200p10]).
The other example of a model cited by the authors describes the chain-free initiative in Mogadishu, Somalia. This model includes three phases. In phase 1, chains are literally removed from patients; in phase 2, professionals visit patients at home and provide family psychosocial education; and in phase 3, the focus is on “removing the ‘invisible chains’ of stigma and restrictions affecting the human rights of persons with mental illness.” Thanks to this initiative, more former patients reportedly are living in the community, and the community has greater awareness about the rights of people with severe mental illness.
Reducing stigma is critical, as this factor has the capacity to determine the prognosis of schizophrenia. Let’s toss out terms describing people with schizophrenia such as “crazy,” “dangerous,” “not manageable at home,” “unemployable,” and “unable to function in society.”
In 2012, the 5th Geneva Conference on Person-Centered Medicine made several recommendations that incorporate many of the principles promoted by Fountain House and the chain-free initiative. They include integrating health promotion and illness prevention; engaging health services in prevention, diagnosis, and treatment of diseases through multidisciplinary approaches; collaborating closely on clinical care and public health; engaging civil society in such efforts.
Health care workers across the globe face big challenges when it comes to managing schizophrenia. Those of us practicing medicine in developing and developed countries must educate, raise awareness, and mobilize resources in the fight against the illness.
Schizophrenia remains a major global mental health problem, but living with the illness has become possible. Perhaps 10 to 20 years down the road, we will be closer to identifying a cause, and this discovery, in turn, might lead to new horizons for treatment.
Dr. Gadit is a professor of psychiatry at the University of Toronto.
Vitamin D deficiency associated with Alzheimer’s
Our relationship with vitamins and supplements may be approach-avoidance. On one hand, if they are beneficial and patients are motivated to take them, we do not complain. This is likely a marker of motivated patient who may heed other health promotional advice that we proffer. On the other hand, it is difficult to keep up with the massive amount of good and bad literature about them. Patients can challenge us on our medical knowledge, pinging our opinions about the latest findings tweeted out while we struggle to keep up with all the wheelchair forms.
Vitamins are clearly not consistently beneficial. B vitamins may increase lung cancer risk in smokers. Vitamin D, however, seems to have some of the greatest “staying power” in the clinical realm and has a good reputation as far as vitamins go. Vitamin D is probably good for the heart, but how about the head? Could low D cause dementia? If so, how?
Previous studies of the relationship between vitamin D and dementia have not shown consistent results. Thomas Littlejohns, M.Sc., and colleagues have published a fantastic piece of work (Neurology 2014 Aug. 6 [doi: 10.1212/WNL.0000000000000755]) that sheds some light. They evaluated a prospective cohort of 1,658 elderly ambulatory adults with no history of dementia, CVD, or stroke who had baseline 25-hydroxyvitamin D [25(OH)D] concentrations at baseline. Severely low levels of 25(OH)D and deficiency (≥25 to <50 nmol/L) were associated with a significantly increased risk for all-cause dementia and Alzheimer’s dementia.
Several hypotheses exist as to why vitamin D helps the brain. Vitamin D may attenuate amyloid-induced cytotoxicity and neural apoptosis. It also may reduce the risk of strokes by promoting healthy cerebral vasculature.
The Institute of Medicine recommends a serum concentration of 25(OH)D at 50 nmol/L. This study would suggest that sufficiency to this level is neuroprotective. The next step is to see if supplementation can modify baseline risk, but many of my patients may wait for these data to come out before starting their vitamin D supplements.
Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.
Our relationship with vitamins and supplements may be approach-avoidance. On one hand, if they are beneficial and patients are motivated to take them, we do not complain. This is likely a marker of motivated patient who may heed other health promotional advice that we proffer. On the other hand, it is difficult to keep up with the massive amount of good and bad literature about them. Patients can challenge us on our medical knowledge, pinging our opinions about the latest findings tweeted out while we struggle to keep up with all the wheelchair forms.
Vitamins are clearly not consistently beneficial. B vitamins may increase lung cancer risk in smokers. Vitamin D, however, seems to have some of the greatest “staying power” in the clinical realm and has a good reputation as far as vitamins go. Vitamin D is probably good for the heart, but how about the head? Could low D cause dementia? If so, how?
Previous studies of the relationship between vitamin D and dementia have not shown consistent results. Thomas Littlejohns, M.Sc., and colleagues have published a fantastic piece of work (Neurology 2014 Aug. 6 [doi: 10.1212/WNL.0000000000000755]) that sheds some light. They evaluated a prospective cohort of 1,658 elderly ambulatory adults with no history of dementia, CVD, or stroke who had baseline 25-hydroxyvitamin D [25(OH)D] concentrations at baseline. Severely low levels of 25(OH)D and deficiency (≥25 to <50 nmol/L) were associated with a significantly increased risk for all-cause dementia and Alzheimer’s dementia.
Several hypotheses exist as to why vitamin D helps the brain. Vitamin D may attenuate amyloid-induced cytotoxicity and neural apoptosis. It also may reduce the risk of strokes by promoting healthy cerebral vasculature.
The Institute of Medicine recommends a serum concentration of 25(OH)D at 50 nmol/L. This study would suggest that sufficiency to this level is neuroprotective. The next step is to see if supplementation can modify baseline risk, but many of my patients may wait for these data to come out before starting their vitamin D supplements.
Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.
Our relationship with vitamins and supplements may be approach-avoidance. On one hand, if they are beneficial and patients are motivated to take them, we do not complain. This is likely a marker of motivated patient who may heed other health promotional advice that we proffer. On the other hand, it is difficult to keep up with the massive amount of good and bad literature about them. Patients can challenge us on our medical knowledge, pinging our opinions about the latest findings tweeted out while we struggle to keep up with all the wheelchair forms.
Vitamins are clearly not consistently beneficial. B vitamins may increase lung cancer risk in smokers. Vitamin D, however, seems to have some of the greatest “staying power” in the clinical realm and has a good reputation as far as vitamins go. Vitamin D is probably good for the heart, but how about the head? Could low D cause dementia? If so, how?
Previous studies of the relationship between vitamin D and dementia have not shown consistent results. Thomas Littlejohns, M.Sc., and colleagues have published a fantastic piece of work (Neurology 2014 Aug. 6 [doi: 10.1212/WNL.0000000000000755]) that sheds some light. They evaluated a prospective cohort of 1,658 elderly ambulatory adults with no history of dementia, CVD, or stroke who had baseline 25-hydroxyvitamin D [25(OH)D] concentrations at baseline. Severely low levels of 25(OH)D and deficiency (≥25 to <50 nmol/L) were associated with a significantly increased risk for all-cause dementia and Alzheimer’s dementia.
Several hypotheses exist as to why vitamin D helps the brain. Vitamin D may attenuate amyloid-induced cytotoxicity and neural apoptosis. It also may reduce the risk of strokes by promoting healthy cerebral vasculature.
The Institute of Medicine recommends a serum concentration of 25(OH)D at 50 nmol/L. This study would suggest that sufficiency to this level is neuroprotective. The next step is to see if supplementation can modify baseline risk, but many of my patients may wait for these data to come out before starting their vitamin D supplements.
Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.
Selling your practice
A generation ago, the sale of a medical practice was much like the sale of any other business: A retiring physician would sell his or her practice to a young doctor, and the practice would continue on as before. Occasionally that still happens, but changes in the business of medicine – most significantly the growth of managed care – have had a big impact on the way medical practices are bought and sold.
For one thing, there are far fewer solo practitioners these days, and polls indicate that most young physicians intend to continue that trend. The buyer of a medical practice today is more likely to be an institution, such as a hospital, an HMO, or a large practice group, rather than an individual physician.
Also, because the rules governing such sales have become so numbingly complex, the services of expert (and expensive) third parties are essential.
While these issues may complicate matters, there is still a market for the sale of medical practices. However, you must do everything possible to ensure you identify the best possible buyer and structure the best deal.
The first hurdle is the accurate valuation of your practice, which was covered in some detail last month. For the protection of both parties, it is important that the appraisal be done by an experienced and neutral financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation be supplied to support the conclusions reached.
Keep in mind that the valuation will not necessarily equal the purchase price; other factors may need to be considered before a final price can be agreed upon. Keep in mind, too, that there may be legal constraints on the purchase price. For example, if the buyer is a nonprofit corporation, such as a hospital or HMO, by law it cannot pay in excess of fair market value for the practice – which may rule out any valuation of “good will.” In some states, such as mine (New Jersey), the purchase of private practices by hospitals is prohibited altogether – so you might need to consider a long-term lease rather than a sale.
Once a value has been agreed upon, you must consider how the transaction will be structured. The most popular structures include purchase of assets, purchase of corporate stock, or merger.
Buyers, especially institutional buyers, prefer to purchase assets, because it allows them to pick and choose only those items that have value to them. This can leave the seller with a bunch of “odd lots” to dispose of. But depending on the circumstances, an asset sale may be to the advantage of both parties.
Sellers typically prefer to sell stock because it allows them to sell their entire practice, which is often worth more than the sum of its parts, and often provides tax advantages.
The third option, merger, continues to grow in popularity. I’ll cover some of the more common merger variants in a future column.
Tax issues must always be considered. Most private practices are corporations, and the sale of corporate stock will result in a long-term capital gain which will be taxed (under current law) at 28%. As the saying goes, it’s not what you earn, it’s what you keep; so it may benefit the seller to accept a slightly lower price if the sale can be structured to provide significantly lower tax treatment. However, any gain that does not qualify as a long-term capital gain will be taxed as regular income – currently around 40% – plus a social security tax of about 15%.
Payment in installments is a popular way to defer taxes, since they are incurred on each installment as it is paid. However, such payments may be mistaken by the Internal Revenue Service for payments for referrals, which is illegal. And there is always the problem of making certain all the payments are made.
The seller may wish to continue working at the practice as an employee, and this is often to the buyer’s advantage as well. Transitioning to new ownership in stages often maximizes the value of the business by improving patient retention, and allows patients to become accustomed to the transition. However, care must be taken, with the aid of good legal advice, to structure such an arrangement in a way that minimizes concerns of fraud and abuse.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Skin & Allergy News. Additional columns are available online at edermatologynews.com.
A generation ago, the sale of a medical practice was much like the sale of any other business: A retiring physician would sell his or her practice to a young doctor, and the practice would continue on as before. Occasionally that still happens, but changes in the business of medicine – most significantly the growth of managed care – have had a big impact on the way medical practices are bought and sold.
For one thing, there are far fewer solo practitioners these days, and polls indicate that most young physicians intend to continue that trend. The buyer of a medical practice today is more likely to be an institution, such as a hospital, an HMO, or a large practice group, rather than an individual physician.
Also, because the rules governing such sales have become so numbingly complex, the services of expert (and expensive) third parties are essential.
While these issues may complicate matters, there is still a market for the sale of medical practices. However, you must do everything possible to ensure you identify the best possible buyer and structure the best deal.
The first hurdle is the accurate valuation of your practice, which was covered in some detail last month. For the protection of both parties, it is important that the appraisal be done by an experienced and neutral financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation be supplied to support the conclusions reached.
Keep in mind that the valuation will not necessarily equal the purchase price; other factors may need to be considered before a final price can be agreed upon. Keep in mind, too, that there may be legal constraints on the purchase price. For example, if the buyer is a nonprofit corporation, such as a hospital or HMO, by law it cannot pay in excess of fair market value for the practice – which may rule out any valuation of “good will.” In some states, such as mine (New Jersey), the purchase of private practices by hospitals is prohibited altogether – so you might need to consider a long-term lease rather than a sale.
Once a value has been agreed upon, you must consider how the transaction will be structured. The most popular structures include purchase of assets, purchase of corporate stock, or merger.
Buyers, especially institutional buyers, prefer to purchase assets, because it allows them to pick and choose only those items that have value to them. This can leave the seller with a bunch of “odd lots” to dispose of. But depending on the circumstances, an asset sale may be to the advantage of both parties.
Sellers typically prefer to sell stock because it allows them to sell their entire practice, which is often worth more than the sum of its parts, and often provides tax advantages.
The third option, merger, continues to grow in popularity. I’ll cover some of the more common merger variants in a future column.
Tax issues must always be considered. Most private practices are corporations, and the sale of corporate stock will result in a long-term capital gain which will be taxed (under current law) at 28%. As the saying goes, it’s not what you earn, it’s what you keep; so it may benefit the seller to accept a slightly lower price if the sale can be structured to provide significantly lower tax treatment. However, any gain that does not qualify as a long-term capital gain will be taxed as regular income – currently around 40% – plus a social security tax of about 15%.
Payment in installments is a popular way to defer taxes, since they are incurred on each installment as it is paid. However, such payments may be mistaken by the Internal Revenue Service for payments for referrals, which is illegal. And there is always the problem of making certain all the payments are made.
The seller may wish to continue working at the practice as an employee, and this is often to the buyer’s advantage as well. Transitioning to new ownership in stages often maximizes the value of the business by improving patient retention, and allows patients to become accustomed to the transition. However, care must be taken, with the aid of good legal advice, to structure such an arrangement in a way that minimizes concerns of fraud and abuse.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Skin & Allergy News. Additional columns are available online at edermatologynews.com.
A generation ago, the sale of a medical practice was much like the sale of any other business: A retiring physician would sell his or her practice to a young doctor, and the practice would continue on as before. Occasionally that still happens, but changes in the business of medicine – most significantly the growth of managed care – have had a big impact on the way medical practices are bought and sold.
For one thing, there are far fewer solo practitioners these days, and polls indicate that most young physicians intend to continue that trend. The buyer of a medical practice today is more likely to be an institution, such as a hospital, an HMO, or a large practice group, rather than an individual physician.
Also, because the rules governing such sales have become so numbingly complex, the services of expert (and expensive) third parties are essential.
While these issues may complicate matters, there is still a market for the sale of medical practices. However, you must do everything possible to ensure you identify the best possible buyer and structure the best deal.
The first hurdle is the accurate valuation of your practice, which was covered in some detail last month. For the protection of both parties, it is important that the appraisal be done by an experienced and neutral financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation be supplied to support the conclusions reached.
Keep in mind that the valuation will not necessarily equal the purchase price; other factors may need to be considered before a final price can be agreed upon. Keep in mind, too, that there may be legal constraints on the purchase price. For example, if the buyer is a nonprofit corporation, such as a hospital or HMO, by law it cannot pay in excess of fair market value for the practice – which may rule out any valuation of “good will.” In some states, such as mine (New Jersey), the purchase of private practices by hospitals is prohibited altogether – so you might need to consider a long-term lease rather than a sale.
Once a value has been agreed upon, you must consider how the transaction will be structured. The most popular structures include purchase of assets, purchase of corporate stock, or merger.
Buyers, especially institutional buyers, prefer to purchase assets, because it allows them to pick and choose only those items that have value to them. This can leave the seller with a bunch of “odd lots” to dispose of. But depending on the circumstances, an asset sale may be to the advantage of both parties.
Sellers typically prefer to sell stock because it allows them to sell their entire practice, which is often worth more than the sum of its parts, and often provides tax advantages.
The third option, merger, continues to grow in popularity. I’ll cover some of the more common merger variants in a future column.
Tax issues must always be considered. Most private practices are corporations, and the sale of corporate stock will result in a long-term capital gain which will be taxed (under current law) at 28%. As the saying goes, it’s not what you earn, it’s what you keep; so it may benefit the seller to accept a slightly lower price if the sale can be structured to provide significantly lower tax treatment. However, any gain that does not qualify as a long-term capital gain will be taxed as regular income – currently around 40% – plus a social security tax of about 15%.
Payment in installments is a popular way to defer taxes, since they are incurred on each installment as it is paid. However, such payments may be mistaken by the Internal Revenue Service for payments for referrals, which is illegal. And there is always the problem of making certain all the payments are made.
The seller may wish to continue working at the practice as an employee, and this is often to the buyer’s advantage as well. Transitioning to new ownership in stages often maximizes the value of the business by improving patient retention, and allows patients to become accustomed to the transition. However, care must be taken, with the aid of good legal advice, to structure such an arrangement in a way that minimizes concerns of fraud and abuse.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Skin & Allergy News. Additional columns are available online at edermatologynews.com.
Cancer Survivorship Care
Skolarus and Hawley alerted us to the large numbers of prostate cancer survivors in the VA.1 Prostate cancer is the most common male cancer. Many are cured, and those not cured generally have a long survival. There are adverse effects (AEs) to the curative procedures, including erectile dysfunction, urinary incontinence, and proctitis after radiation therapy. All those AEs require patients to seek professional attention over many years from their primary care providers (PCPs) and their oncologist/urologist. But fulfilling survivors' needs goes beyond those doctors who can effectively address physical impairments.
According to the Institute of Medicine, hospital discharge requires not only a warm goodbye, but also a written document that includes in lay terms the precise cancer and the precise treatment(s).2 This care plan must include a shared recognition of possible recurrence, how that might be detected early, and a list of recommended periodic tests (mammogram, PSA, etc). The plans should serve to lessen the anxiety and may suggest sources of support, of job finding, of retraining. It may also mention the remarkable collaborative role local American Cancer Society units have undertaken serving cancer survivors.
The one social worker at our VA clinic provides support to all survivors in a weekly open get-together. Psychologists, pharmacists, and oncologists may attend these meetings. The focus is on allowing patients to express concerns and share personal issues, such as incontinence and sexual dysfunction, in a safe and understanding environment. Veterans do not easily share deep feelings or ask for help. But here they provide various interventions, learn of multiple community possibilities, discuss loneliness, share their unfulfilled social needs, and express the stress of possible recurrences.
The PCPs and oncologist/urologist identified in the Skolarus/Hawley article are needed for possibly correcting physical impairments, but there are others, such as social workers, American Cancer Society teams, psychologists, etc, who are better at helping patients adjust to their impairments.
Everett Shocket, MD, MSurg
Jennifer Feeney, LCSW
Bay Pines VAMC, Sarasota Florida
Editor's Note: For guidance on creating cancer survivorship plans, visit FedPrac.com/AVAHO.
Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.
1. Skolarus TA, Hawley ST. Prostate cancer survivorship care. Fed Pract. 2014;31(8):10-17.
2. Hewitt M, Greenfield S, Stovall E, eds. From Cancer Patient to Cancer Survivor: Lost in Transition. Washington, DC: The National Academies Press; 2005.
Skolarus and Hawley alerted us to the large numbers of prostate cancer survivors in the VA.1 Prostate cancer is the most common male cancer. Many are cured, and those not cured generally have a long survival. There are adverse effects (AEs) to the curative procedures, including erectile dysfunction, urinary incontinence, and proctitis after radiation therapy. All those AEs require patients to seek professional attention over many years from their primary care providers (PCPs) and their oncologist/urologist. But fulfilling survivors' needs goes beyond those doctors who can effectively address physical impairments.
According to the Institute of Medicine, hospital discharge requires not only a warm goodbye, but also a written document that includes in lay terms the precise cancer and the precise treatment(s).2 This care plan must include a shared recognition of possible recurrence, how that might be detected early, and a list of recommended periodic tests (mammogram, PSA, etc). The plans should serve to lessen the anxiety and may suggest sources of support, of job finding, of retraining. It may also mention the remarkable collaborative role local American Cancer Society units have undertaken serving cancer survivors.
The one social worker at our VA clinic provides support to all survivors in a weekly open get-together. Psychologists, pharmacists, and oncologists may attend these meetings. The focus is on allowing patients to express concerns and share personal issues, such as incontinence and sexual dysfunction, in a safe and understanding environment. Veterans do not easily share deep feelings or ask for help. But here they provide various interventions, learn of multiple community possibilities, discuss loneliness, share their unfulfilled social needs, and express the stress of possible recurrences.
The PCPs and oncologist/urologist identified in the Skolarus/Hawley article are needed for possibly correcting physical impairments, but there are others, such as social workers, American Cancer Society teams, psychologists, etc, who are better at helping patients adjust to their impairments.
Everett Shocket, MD, MSurg
Jennifer Feeney, LCSW
Bay Pines VAMC, Sarasota Florida
Editor's Note: For guidance on creating cancer survivorship plans, visit FedPrac.com/AVAHO.
Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.
Skolarus and Hawley alerted us to the large numbers of prostate cancer survivors in the VA.1 Prostate cancer is the most common male cancer. Many are cured, and those not cured generally have a long survival. There are adverse effects (AEs) to the curative procedures, including erectile dysfunction, urinary incontinence, and proctitis after radiation therapy. All those AEs require patients to seek professional attention over many years from their primary care providers (PCPs) and their oncologist/urologist. But fulfilling survivors' needs goes beyond those doctors who can effectively address physical impairments.
According to the Institute of Medicine, hospital discharge requires not only a warm goodbye, but also a written document that includes in lay terms the precise cancer and the precise treatment(s).2 This care plan must include a shared recognition of possible recurrence, how that might be detected early, and a list of recommended periodic tests (mammogram, PSA, etc). The plans should serve to lessen the anxiety and may suggest sources of support, of job finding, of retraining. It may also mention the remarkable collaborative role local American Cancer Society units have undertaken serving cancer survivors.
The one social worker at our VA clinic provides support to all survivors in a weekly open get-together. Psychologists, pharmacists, and oncologists may attend these meetings. The focus is on allowing patients to express concerns and share personal issues, such as incontinence and sexual dysfunction, in a safe and understanding environment. Veterans do not easily share deep feelings or ask for help. But here they provide various interventions, learn of multiple community possibilities, discuss loneliness, share their unfulfilled social needs, and express the stress of possible recurrences.
The PCPs and oncologist/urologist identified in the Skolarus/Hawley article are needed for possibly correcting physical impairments, but there are others, such as social workers, American Cancer Society teams, psychologists, etc, who are better at helping patients adjust to their impairments.
Everett Shocket, MD, MSurg
Jennifer Feeney, LCSW
Bay Pines VAMC, Sarasota Florida
Editor's Note: For guidance on creating cancer survivorship plans, visit FedPrac.com/AVAHO.
Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.
1. Skolarus TA, Hawley ST. Prostate cancer survivorship care. Fed Pract. 2014;31(8):10-17.
2. Hewitt M, Greenfield S, Stovall E, eds. From Cancer Patient to Cancer Survivor: Lost in Transition. Washington, DC: The National Academies Press; 2005.
1. Skolarus TA, Hawley ST. Prostate cancer survivorship care. Fed Pract. 2014;31(8):10-17.
2. Hewitt M, Greenfield S, Stovall E, eds. From Cancer Patient to Cancer Survivor: Lost in Transition. Washington, DC: The National Academies Press; 2005.
Last night I had a nightmare
In the dream I had an asymptomatic 5.7-cm juxtarenal abdominal aortic aneurysm. Like most of my patients I also had a 70% left internal carotid stenosis and nondisabling right leg claudication due to a superficial femoral artery stenosis. Having stood at the operating table for most of my life, my varicose veins were ugly but fortunately did not hurt.
In this dream I decided to first visit my family physician. He insisted that I stop smoking, but I had already quit 30 years ago. He was unaware of this as he had not updated his new electronic medical record system. He said “Jim, you have to take a statin. I would like to treat you with Crestor but your insurance carrier won’t pay for it. Try some red rice yeast.” I forgave him for not knowing that my name was Russell. After all, he was seeing 150 patients that day just to make ends meet and seemed rushed.
Unhappy with this consultation, I sought out one of the new concierge doctors in town. He gave me professional courtesy and charged me only a retainer of $7,000 a year. He ordered a stress test, CTA, MRI, bone scan, hypercoagulable and lipid blood analysis, and full metabolic profile. A vascular lab tech who came to his office once a week repeated my aortic, venous, carotid, and lower-extremity arterial vascular studies.
The doctor informed me that a radiologist in some other country would be reading the test, but he was sure it would be reliable. When the results came back I now had “Critical 95% carotid stenoses bilaterally,” and my AAA had “inexplicably” grown to 8.5 cm. I also had “limb-threatening severe PAD.” He recommended that I see his favorite cardiologist whom he felt could easily treat all these conditions and my aneurysm. Then, as a favor, he drove me to that appointment in his new Ferrari.
The cardiologist’s eyes gleamed when he saw me. He was an older gentleman wearing a tight-fitting all-in-one red satin suit and constantly plucked at his pointy beard. He had breath that smelled of sulfur. He seemed distracted by something pointed that appeared to be coming out of the back of his pants. His sharp ears tilted forward as he listened to me. He tried to convince me that no matter how I elected to have my aneurysm treated he should stent my carotid first, followed by an atherectomy and stent to open up my superficial femoral artery to prevent an amputation.
Furthermore, he was quite certain that I would get a DVT if I did not let him laser my great saphenous veins. After he had performed these procedures he would treat my AAA with a percutaneous endograft which he was planning to do in his outpatient cath lab. As this was early in my dream, my subconscious still had some control, and so, wisely, I declined to consent. He told me that “One way or another I will eventually get to take care of you!” I must say I was disconcerted by his words since I had a feeling he implied something entirely different.
Terrified, I sought someone competent to take care of my aneurysm. Clearly, as a practicing vascular surgeon myself, I had a pretty good idea as to who would be best, but I could not decide between the young, hotshot endovascular surgeon or the older vascular surgeon who had performed hundreds of open procedures and also performed many endovascular aneurysm repairs. I decided to visit the young surgeon first. After all, even though I was in a dream, I didn’t want to suffer the pain and recovery of an open procedure. He was confident he could help me by was using a new self-constructed fenestrated graft that he had made from scratch in his research lab at the university. Recently he had presented his series of two patients at Vascular Interventional Advances. Both patients had done “very well.” The first patient was still in the intensive care unit 4 weeks after the implant but he expected she would be off the respirator and dialysis soon. The second patient was thrilled that he was getting back some function in his toes after developing spinal paresis.
The older surgeon was also not reassuring. Although he had done hundreds of open AAAs in the past, with the advent of endovascular therapies, over the last few years he felt compelled to use this new less invasive technology. Furthermore, he was quite sure that virtually every aneurysm in his community had already been treated by a gamut of different specialists. The result was that he was performing only a handful of open aneurysms a year. Like many other surgeons of his era he had become less certain of his open surgical skills. He told me that, whereas when he was younger he would sleep soundly the night before a major complex aortic procedure, he now spent the night worrying. Perhaps it was the bags around his eyes, the drooping shoulders, and the slight tremor in his hands that suggested that he might not be the best surgeon for my aneurysm.
So I went back to the young surgeon and asked him if he could do an open operation. He shrugged his shoulders, and with some chagrin he explained he had done only one in his vascular residency. This was not only because there were so few aneurysms treated open, but because his OR time was reduced as a result of a mandate that residents could not work more than 40 hours a week and had to have at least 8 hours of sleep every night.
On the other hand, he had won the “Top Gun” competition at the Society for Clinical Vascular Surgery where he had successfully completed an aortic aneurysm surgery on a plastic mannequin. However, now in his first 3 years in practice he employed only endovascular techniques. He assured me, though, that he would read a textbook before the operation. Walking out of his office I noticed a framed picture in which he was surrounded by his beaming mother and grandmother as he was delivering the valedictorian speech at his grade school graduation.
The sheets were drenched with perspiration, and I cried out in my sleep, waking my wife.
“Who is going to be able to fix my aneurysm?” I said, waking myself.
“Calm down,” she said. “It’s only a dream.”
But was it? Are we training enough young surgeons in open surgery to maintain the surgical skills necessary to safely perform complex aneurysm surgery? Are our older surgeons maintaining proficiency as more and more procedures are performed percutaneously? Are the inroads from other specialties reducing overall aneurysm experience? Is the improvement in medical management slowing aneurysm growth and prevalence? Time will tell, but I believe training programs should be developing shared opportunities where programs strong in open procedures exchange their fellows with programs incorporating high-volume endovascular approaches. Further, older surgeons may need to refresh their skills in both open and endovascular procedures. Otherwise we may have to concede that Centers of Excellence may be the only way that patients can receive optimal care.
In the dream I had an asymptomatic 5.7-cm juxtarenal abdominal aortic aneurysm. Like most of my patients I also had a 70% left internal carotid stenosis and nondisabling right leg claudication due to a superficial femoral artery stenosis. Having stood at the operating table for most of my life, my varicose veins were ugly but fortunately did not hurt.
In this dream I decided to first visit my family physician. He insisted that I stop smoking, but I had already quit 30 years ago. He was unaware of this as he had not updated his new electronic medical record system. He said “Jim, you have to take a statin. I would like to treat you with Crestor but your insurance carrier won’t pay for it. Try some red rice yeast.” I forgave him for not knowing that my name was Russell. After all, he was seeing 150 patients that day just to make ends meet and seemed rushed.
Unhappy with this consultation, I sought out one of the new concierge doctors in town. He gave me professional courtesy and charged me only a retainer of $7,000 a year. He ordered a stress test, CTA, MRI, bone scan, hypercoagulable and lipid blood analysis, and full metabolic profile. A vascular lab tech who came to his office once a week repeated my aortic, venous, carotid, and lower-extremity arterial vascular studies.
The doctor informed me that a radiologist in some other country would be reading the test, but he was sure it would be reliable. When the results came back I now had “Critical 95% carotid stenoses bilaterally,” and my AAA had “inexplicably” grown to 8.5 cm. I also had “limb-threatening severe PAD.” He recommended that I see his favorite cardiologist whom he felt could easily treat all these conditions and my aneurysm. Then, as a favor, he drove me to that appointment in his new Ferrari.
The cardiologist’s eyes gleamed when he saw me. He was an older gentleman wearing a tight-fitting all-in-one red satin suit and constantly plucked at his pointy beard. He had breath that smelled of sulfur. He seemed distracted by something pointed that appeared to be coming out of the back of his pants. His sharp ears tilted forward as he listened to me. He tried to convince me that no matter how I elected to have my aneurysm treated he should stent my carotid first, followed by an atherectomy and stent to open up my superficial femoral artery to prevent an amputation.
Furthermore, he was quite certain that I would get a DVT if I did not let him laser my great saphenous veins. After he had performed these procedures he would treat my AAA with a percutaneous endograft which he was planning to do in his outpatient cath lab. As this was early in my dream, my subconscious still had some control, and so, wisely, I declined to consent. He told me that “One way or another I will eventually get to take care of you!” I must say I was disconcerted by his words since I had a feeling he implied something entirely different.
Terrified, I sought someone competent to take care of my aneurysm. Clearly, as a practicing vascular surgeon myself, I had a pretty good idea as to who would be best, but I could not decide between the young, hotshot endovascular surgeon or the older vascular surgeon who had performed hundreds of open procedures and also performed many endovascular aneurysm repairs. I decided to visit the young surgeon first. After all, even though I was in a dream, I didn’t want to suffer the pain and recovery of an open procedure. He was confident he could help me by was using a new self-constructed fenestrated graft that he had made from scratch in his research lab at the university. Recently he had presented his series of two patients at Vascular Interventional Advances. Both patients had done “very well.” The first patient was still in the intensive care unit 4 weeks after the implant but he expected she would be off the respirator and dialysis soon. The second patient was thrilled that he was getting back some function in his toes after developing spinal paresis.
The older surgeon was also not reassuring. Although he had done hundreds of open AAAs in the past, with the advent of endovascular therapies, over the last few years he felt compelled to use this new less invasive technology. Furthermore, he was quite sure that virtually every aneurysm in his community had already been treated by a gamut of different specialists. The result was that he was performing only a handful of open aneurysms a year. Like many other surgeons of his era he had become less certain of his open surgical skills. He told me that, whereas when he was younger he would sleep soundly the night before a major complex aortic procedure, he now spent the night worrying. Perhaps it was the bags around his eyes, the drooping shoulders, and the slight tremor in his hands that suggested that he might not be the best surgeon for my aneurysm.
So I went back to the young surgeon and asked him if he could do an open operation. He shrugged his shoulders, and with some chagrin he explained he had done only one in his vascular residency. This was not only because there were so few aneurysms treated open, but because his OR time was reduced as a result of a mandate that residents could not work more than 40 hours a week and had to have at least 8 hours of sleep every night.
On the other hand, he had won the “Top Gun” competition at the Society for Clinical Vascular Surgery where he had successfully completed an aortic aneurysm surgery on a plastic mannequin. However, now in his first 3 years in practice he employed only endovascular techniques. He assured me, though, that he would read a textbook before the operation. Walking out of his office I noticed a framed picture in which he was surrounded by his beaming mother and grandmother as he was delivering the valedictorian speech at his grade school graduation.
The sheets were drenched with perspiration, and I cried out in my sleep, waking my wife.
“Who is going to be able to fix my aneurysm?” I said, waking myself.
“Calm down,” she said. “It’s only a dream.”
But was it? Are we training enough young surgeons in open surgery to maintain the surgical skills necessary to safely perform complex aneurysm surgery? Are our older surgeons maintaining proficiency as more and more procedures are performed percutaneously? Are the inroads from other specialties reducing overall aneurysm experience? Is the improvement in medical management slowing aneurysm growth and prevalence? Time will tell, but I believe training programs should be developing shared opportunities where programs strong in open procedures exchange their fellows with programs incorporating high-volume endovascular approaches. Further, older surgeons may need to refresh their skills in both open and endovascular procedures. Otherwise we may have to concede that Centers of Excellence may be the only way that patients can receive optimal care.
In the dream I had an asymptomatic 5.7-cm juxtarenal abdominal aortic aneurysm. Like most of my patients I also had a 70% left internal carotid stenosis and nondisabling right leg claudication due to a superficial femoral artery stenosis. Having stood at the operating table for most of my life, my varicose veins were ugly but fortunately did not hurt.
In this dream I decided to first visit my family physician. He insisted that I stop smoking, but I had already quit 30 years ago. He was unaware of this as he had not updated his new electronic medical record system. He said “Jim, you have to take a statin. I would like to treat you with Crestor but your insurance carrier won’t pay for it. Try some red rice yeast.” I forgave him for not knowing that my name was Russell. After all, he was seeing 150 patients that day just to make ends meet and seemed rushed.
Unhappy with this consultation, I sought out one of the new concierge doctors in town. He gave me professional courtesy and charged me only a retainer of $7,000 a year. He ordered a stress test, CTA, MRI, bone scan, hypercoagulable and lipid blood analysis, and full metabolic profile. A vascular lab tech who came to his office once a week repeated my aortic, venous, carotid, and lower-extremity arterial vascular studies.
The doctor informed me that a radiologist in some other country would be reading the test, but he was sure it would be reliable. When the results came back I now had “Critical 95% carotid stenoses bilaterally,” and my AAA had “inexplicably” grown to 8.5 cm. I also had “limb-threatening severe PAD.” He recommended that I see his favorite cardiologist whom he felt could easily treat all these conditions and my aneurysm. Then, as a favor, he drove me to that appointment in his new Ferrari.
The cardiologist’s eyes gleamed when he saw me. He was an older gentleman wearing a tight-fitting all-in-one red satin suit and constantly plucked at his pointy beard. He had breath that smelled of sulfur. He seemed distracted by something pointed that appeared to be coming out of the back of his pants. His sharp ears tilted forward as he listened to me. He tried to convince me that no matter how I elected to have my aneurysm treated he should stent my carotid first, followed by an atherectomy and stent to open up my superficial femoral artery to prevent an amputation.
Furthermore, he was quite certain that I would get a DVT if I did not let him laser my great saphenous veins. After he had performed these procedures he would treat my AAA with a percutaneous endograft which he was planning to do in his outpatient cath lab. As this was early in my dream, my subconscious still had some control, and so, wisely, I declined to consent. He told me that “One way or another I will eventually get to take care of you!” I must say I was disconcerted by his words since I had a feeling he implied something entirely different.
Terrified, I sought someone competent to take care of my aneurysm. Clearly, as a practicing vascular surgeon myself, I had a pretty good idea as to who would be best, but I could not decide between the young, hotshot endovascular surgeon or the older vascular surgeon who had performed hundreds of open procedures and also performed many endovascular aneurysm repairs. I decided to visit the young surgeon first. After all, even though I was in a dream, I didn’t want to suffer the pain and recovery of an open procedure. He was confident he could help me by was using a new self-constructed fenestrated graft that he had made from scratch in his research lab at the university. Recently he had presented his series of two patients at Vascular Interventional Advances. Both patients had done “very well.” The first patient was still in the intensive care unit 4 weeks after the implant but he expected she would be off the respirator and dialysis soon. The second patient was thrilled that he was getting back some function in his toes after developing spinal paresis.
The older surgeon was also not reassuring. Although he had done hundreds of open AAAs in the past, with the advent of endovascular therapies, over the last few years he felt compelled to use this new less invasive technology. Furthermore, he was quite sure that virtually every aneurysm in his community had already been treated by a gamut of different specialists. The result was that he was performing only a handful of open aneurysms a year. Like many other surgeons of his era he had become less certain of his open surgical skills. He told me that, whereas when he was younger he would sleep soundly the night before a major complex aortic procedure, he now spent the night worrying. Perhaps it was the bags around his eyes, the drooping shoulders, and the slight tremor in his hands that suggested that he might not be the best surgeon for my aneurysm.
So I went back to the young surgeon and asked him if he could do an open operation. He shrugged his shoulders, and with some chagrin he explained he had done only one in his vascular residency. This was not only because there were so few aneurysms treated open, but because his OR time was reduced as a result of a mandate that residents could not work more than 40 hours a week and had to have at least 8 hours of sleep every night.
On the other hand, he had won the “Top Gun” competition at the Society for Clinical Vascular Surgery where he had successfully completed an aortic aneurysm surgery on a plastic mannequin. However, now in his first 3 years in practice he employed only endovascular techniques. He assured me, though, that he would read a textbook before the operation. Walking out of his office I noticed a framed picture in which he was surrounded by his beaming mother and grandmother as he was delivering the valedictorian speech at his grade school graduation.
The sheets were drenched with perspiration, and I cried out in my sleep, waking my wife.
“Who is going to be able to fix my aneurysm?” I said, waking myself.
“Calm down,” she said. “It’s only a dream.”
But was it? Are we training enough young surgeons in open surgery to maintain the surgical skills necessary to safely perform complex aneurysm surgery? Are our older surgeons maintaining proficiency as more and more procedures are performed percutaneously? Are the inroads from other specialties reducing overall aneurysm experience? Is the improvement in medical management slowing aneurysm growth and prevalence? Time will tell, but I believe training programs should be developing shared opportunities where programs strong in open procedures exchange their fellows with programs incorporating high-volume endovascular approaches. Further, older surgeons may need to refresh their skills in both open and endovascular procedures. Otherwise we may have to concede that Centers of Excellence may be the only way that patients can receive optimal care.
Adnexal masses in pregnancy
With the increasing use of ultrasound in the first trimester, asymptomatic adnexal masses are being diagnosed earlier in pregnancy, leaving providers with an often difficult clinical scenario. The reported incidence of adnexal masses ranges from 1 in 81 to 1 in 8,000 pregnancies, and 0.93%-6% of these are malignant (Gynecol. Oncol. 2006;101:315-21; Am. J. Obstet. Gynecol. 1999;181:19-24). In light of this, the importance of recognizing adnexal masses and knowledge of their management are crucial for any practicing obstetrician gynecologist.
Differential diagnosis
In pregnancy, the majority of adnexal masses are benign simple cysts less than 5 cm (BJOG 2003;110:578-83). As such, the majority of masses (probable corpus luteum cysts) detected in the first trimester (70% in one study) will resolve by the early part of the second trimester (Clin. Obstet. Gynecol. 2006;49:492-505). Adnexal masses are commonly physiologic or functional cysts. Benign masses with complex features can include corpus luteum, mature teratomas, hydrosalpinx, theca lutein cysts, or endometriomas. Complex adnexal masses greater than 5 cm are most likely mature teratomas (Am. J. Obstet. Gynecol. 2001;184:1504-12). Degenerating or pedunculated fibroids can mimic an adnexal mass and may cause pain, clouding the diagnosis.
Of the rare malignant lesions that occur in pregnancy, approximately half are epithelial tumors and one-third are germ cell tumors. Of the epithelial neoplasms, up to 50% may be low-malignant-potential tumors.
Diagnostic evaluation
Imaging: Transvaginal ultrasound is regarded as the modality of choice when evaluating adnexal pathology. Abdominal ultrasound may be especially helpful when the ovaries are outside of the pelvis, especially later in gestation. MRI without contrast may aid in distinguishing leiomyoma and ovarian pathology, which is vital when planning surgery. However, MRI with gadolinium is not recommended as its safety in pregnancy has not been established.
Tumor markers: None of the available tumor markers may be reliably used to diagnose ovarian cancer in pregnancy. CA-125 is elevated in epithelial ovarian cancer, but it is also elevated in pregnancy. However, significant elevations (greater than 1,000 U/mL) are more likely to be associated with cancer.
Markers for germ cell tumors include alpha-fetoprotein (AFP), lactate dehydrogenase (LDH), and human chorionic gonadotropin (hCG). Maternal serum levels of AFP (MSAFP) normally rise in pregnancy, although extreme values (less than 500 ng/mL) are associated with neural tube defects while levels greater than 1,000 ng/mL may be associated with an ovarian germ cell tumor (especially when greater than 10,000 ng/mL). LDH is elevated in women with ovarian dysgerminomas and is reliable in pregnancy outside of HELLP syndrome (hemolysis, elevated liver enzymes, low platelets). Of course, hCG is elevated in pregnancy, negating its value as a germ cell tumor marker. Inhibin B may be elevated in association with granulosa cell tumors; however, it is also elevated in early gestation.
Management
Because most corpus luteum will resolve, it is recommended to electively resect adnexal masses in the second trimester when they meet the following criteria: lesions are greater than 10 cm in diameter; they are complex lesions (Fertil. Steril. 2009;91:1895-902; Obstet. Gynecol. 1999;93:585-9).
Benign-appearing but persistent simple cysts in the second trimester may be managed conservatively, as approximately 70% will resolve. Thus, routine removal of persistent cysts is not recommended (BJOG 2003;110:578-83). Risk factors for persistent lesions include size greater than 5 cm and complex morphology (Obstet. Gynecol. 1999;93:585-9).Providers may consider serial ultrasounds of ovarian cysts to detect an increase in size or change in character that may warrant further investigation.
Surgery is considered in asymptomatic women meeting the above criteria, to diagnose malignancy or reduce the risk of torsion or rupture. Torsion has been found to be more likely in the late first and early second trimester, with only 6% occurring after 20 weeks. Corpus luteum cysts may on occasion persist into the second trimester and can account for up to 17% of all cystic adnexal masses (Am. J. Obstet. Gynecol. 1999;181:19-24). It is important to remember that if a corpus luteum is surgically resected in the first trimester, progesterone needs to be replaced to avoid pregnancy loss. Of those complex lesions diagnosed in the first trimester that persist into the second trimester, up to 10% may be malignant.
Providers who feel comfortable with laparoscopic techniques can proceed with minimally invasive surgery, with optimal timing in the early second trimester (J. Minim. Invasive Gynecol. 2011;18:720-5). Care should be taken to consider fundal height when choosing trocar placement. If there is a high suspicion for malignancy, providers may want to proceed via laparotomy, which should be via a vertical midline incision. Tocolytic therapy given prophylactically at the time of surgery has no proven benefit and should not be routinely administered.
Washings should be obtained and providers should perform a thorough inspection of the abdomen, contralateral ovary, omentum, and peritoneal surfaces. Any suspicious lesions should be biopsied. A simple cystectomy is reasonable with benign lesions; however, a unilateral salpingo-oophorectomy should be performed with frozen confirmation if there are any concerning findings for malignancy. If a malignancy is confirmed, a gynecologic oncologist should be consulted, and surgical staging should be considered.
Dr. Sullivan is a chief resident in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Gehrig is professor and director of gynecologic oncology at the university. Dr. Clarke-Pearson is the chair and the Robert A. Ross Distinguished Professor of Obstetrics and Gynecology, and a professor in the division of gynecologic oncology at the university. Dr. Sullivan, Dr. Gehrig, and Dr. Clarke-Pearson said they had no relevant financial disclosures.
With the increasing use of ultrasound in the first trimester, asymptomatic adnexal masses are being diagnosed earlier in pregnancy, leaving providers with an often difficult clinical scenario. The reported incidence of adnexal masses ranges from 1 in 81 to 1 in 8,000 pregnancies, and 0.93%-6% of these are malignant (Gynecol. Oncol. 2006;101:315-21; Am. J. Obstet. Gynecol. 1999;181:19-24). In light of this, the importance of recognizing adnexal masses and knowledge of their management are crucial for any practicing obstetrician gynecologist.
Differential diagnosis
In pregnancy, the majority of adnexal masses are benign simple cysts less than 5 cm (BJOG 2003;110:578-83). As such, the majority of masses (probable corpus luteum cysts) detected in the first trimester (70% in one study) will resolve by the early part of the second trimester (Clin. Obstet. Gynecol. 2006;49:492-505). Adnexal masses are commonly physiologic or functional cysts. Benign masses with complex features can include corpus luteum, mature teratomas, hydrosalpinx, theca lutein cysts, or endometriomas. Complex adnexal masses greater than 5 cm are most likely mature teratomas (Am. J. Obstet. Gynecol. 2001;184:1504-12). Degenerating or pedunculated fibroids can mimic an adnexal mass and may cause pain, clouding the diagnosis.
Of the rare malignant lesions that occur in pregnancy, approximately half are epithelial tumors and one-third are germ cell tumors. Of the epithelial neoplasms, up to 50% may be low-malignant-potential tumors.
Diagnostic evaluation
Imaging: Transvaginal ultrasound is regarded as the modality of choice when evaluating adnexal pathology. Abdominal ultrasound may be especially helpful when the ovaries are outside of the pelvis, especially later in gestation. MRI without contrast may aid in distinguishing leiomyoma and ovarian pathology, which is vital when planning surgery. However, MRI with gadolinium is not recommended as its safety in pregnancy has not been established.
Tumor markers: None of the available tumor markers may be reliably used to diagnose ovarian cancer in pregnancy. CA-125 is elevated in epithelial ovarian cancer, but it is also elevated in pregnancy. However, significant elevations (greater than 1,000 U/mL) are more likely to be associated with cancer.
Markers for germ cell tumors include alpha-fetoprotein (AFP), lactate dehydrogenase (LDH), and human chorionic gonadotropin (hCG). Maternal serum levels of AFP (MSAFP) normally rise in pregnancy, although extreme values (less than 500 ng/mL) are associated with neural tube defects while levels greater than 1,000 ng/mL may be associated with an ovarian germ cell tumor (especially when greater than 10,000 ng/mL). LDH is elevated in women with ovarian dysgerminomas and is reliable in pregnancy outside of HELLP syndrome (hemolysis, elevated liver enzymes, low platelets). Of course, hCG is elevated in pregnancy, negating its value as a germ cell tumor marker. Inhibin B may be elevated in association with granulosa cell tumors; however, it is also elevated in early gestation.
Management
Because most corpus luteum will resolve, it is recommended to electively resect adnexal masses in the second trimester when they meet the following criteria: lesions are greater than 10 cm in diameter; they are complex lesions (Fertil. Steril. 2009;91:1895-902; Obstet. Gynecol. 1999;93:585-9).
Benign-appearing but persistent simple cysts in the second trimester may be managed conservatively, as approximately 70% will resolve. Thus, routine removal of persistent cysts is not recommended (BJOG 2003;110:578-83). Risk factors for persistent lesions include size greater than 5 cm and complex morphology (Obstet. Gynecol. 1999;93:585-9).Providers may consider serial ultrasounds of ovarian cysts to detect an increase in size or change in character that may warrant further investigation.
Surgery is considered in asymptomatic women meeting the above criteria, to diagnose malignancy or reduce the risk of torsion or rupture. Torsion has been found to be more likely in the late first and early second trimester, with only 6% occurring after 20 weeks. Corpus luteum cysts may on occasion persist into the second trimester and can account for up to 17% of all cystic adnexal masses (Am. J. Obstet. Gynecol. 1999;181:19-24). It is important to remember that if a corpus luteum is surgically resected in the first trimester, progesterone needs to be replaced to avoid pregnancy loss. Of those complex lesions diagnosed in the first trimester that persist into the second trimester, up to 10% may be malignant.
Providers who feel comfortable with laparoscopic techniques can proceed with minimally invasive surgery, with optimal timing in the early second trimester (J. Minim. Invasive Gynecol. 2011;18:720-5). Care should be taken to consider fundal height when choosing trocar placement. If there is a high suspicion for malignancy, providers may want to proceed via laparotomy, which should be via a vertical midline incision. Tocolytic therapy given prophylactically at the time of surgery has no proven benefit and should not be routinely administered.
Washings should be obtained and providers should perform a thorough inspection of the abdomen, contralateral ovary, omentum, and peritoneal surfaces. Any suspicious lesions should be biopsied. A simple cystectomy is reasonable with benign lesions; however, a unilateral salpingo-oophorectomy should be performed with frozen confirmation if there are any concerning findings for malignancy. If a malignancy is confirmed, a gynecologic oncologist should be consulted, and surgical staging should be considered.
Dr. Sullivan is a chief resident in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Gehrig is professor and director of gynecologic oncology at the university. Dr. Clarke-Pearson is the chair and the Robert A. Ross Distinguished Professor of Obstetrics and Gynecology, and a professor in the division of gynecologic oncology at the university. Dr. Sullivan, Dr. Gehrig, and Dr. Clarke-Pearson said they had no relevant financial disclosures.
With the increasing use of ultrasound in the first trimester, asymptomatic adnexal masses are being diagnosed earlier in pregnancy, leaving providers with an often difficult clinical scenario. The reported incidence of adnexal masses ranges from 1 in 81 to 1 in 8,000 pregnancies, and 0.93%-6% of these are malignant (Gynecol. Oncol. 2006;101:315-21; Am. J. Obstet. Gynecol. 1999;181:19-24). In light of this, the importance of recognizing adnexal masses and knowledge of their management are crucial for any practicing obstetrician gynecologist.
Differential diagnosis
In pregnancy, the majority of adnexal masses are benign simple cysts less than 5 cm (BJOG 2003;110:578-83). As such, the majority of masses (probable corpus luteum cysts) detected in the first trimester (70% in one study) will resolve by the early part of the second trimester (Clin. Obstet. Gynecol. 2006;49:492-505). Adnexal masses are commonly physiologic or functional cysts. Benign masses with complex features can include corpus luteum, mature teratomas, hydrosalpinx, theca lutein cysts, or endometriomas. Complex adnexal masses greater than 5 cm are most likely mature teratomas (Am. J. Obstet. Gynecol. 2001;184:1504-12). Degenerating or pedunculated fibroids can mimic an adnexal mass and may cause pain, clouding the diagnosis.
Of the rare malignant lesions that occur in pregnancy, approximately half are epithelial tumors and one-third are germ cell tumors. Of the epithelial neoplasms, up to 50% may be low-malignant-potential tumors.
Diagnostic evaluation
Imaging: Transvaginal ultrasound is regarded as the modality of choice when evaluating adnexal pathology. Abdominal ultrasound may be especially helpful when the ovaries are outside of the pelvis, especially later in gestation. MRI without contrast may aid in distinguishing leiomyoma and ovarian pathology, which is vital when planning surgery. However, MRI with gadolinium is not recommended as its safety in pregnancy has not been established.
Tumor markers: None of the available tumor markers may be reliably used to diagnose ovarian cancer in pregnancy. CA-125 is elevated in epithelial ovarian cancer, but it is also elevated in pregnancy. However, significant elevations (greater than 1,000 U/mL) are more likely to be associated with cancer.
Markers for germ cell tumors include alpha-fetoprotein (AFP), lactate dehydrogenase (LDH), and human chorionic gonadotropin (hCG). Maternal serum levels of AFP (MSAFP) normally rise in pregnancy, although extreme values (less than 500 ng/mL) are associated with neural tube defects while levels greater than 1,000 ng/mL may be associated with an ovarian germ cell tumor (especially when greater than 10,000 ng/mL). LDH is elevated in women with ovarian dysgerminomas and is reliable in pregnancy outside of HELLP syndrome (hemolysis, elevated liver enzymes, low platelets). Of course, hCG is elevated in pregnancy, negating its value as a germ cell tumor marker. Inhibin B may be elevated in association with granulosa cell tumors; however, it is also elevated in early gestation.
Management
Because most corpus luteum will resolve, it is recommended to electively resect adnexal masses in the second trimester when they meet the following criteria: lesions are greater than 10 cm in diameter; they are complex lesions (Fertil. Steril. 2009;91:1895-902; Obstet. Gynecol. 1999;93:585-9).
Benign-appearing but persistent simple cysts in the second trimester may be managed conservatively, as approximately 70% will resolve. Thus, routine removal of persistent cysts is not recommended (BJOG 2003;110:578-83). Risk factors for persistent lesions include size greater than 5 cm and complex morphology (Obstet. Gynecol. 1999;93:585-9).Providers may consider serial ultrasounds of ovarian cysts to detect an increase in size or change in character that may warrant further investigation.
Surgery is considered in asymptomatic women meeting the above criteria, to diagnose malignancy or reduce the risk of torsion or rupture. Torsion has been found to be more likely in the late first and early second trimester, with only 6% occurring after 20 weeks. Corpus luteum cysts may on occasion persist into the second trimester and can account for up to 17% of all cystic adnexal masses (Am. J. Obstet. Gynecol. 1999;181:19-24). It is important to remember that if a corpus luteum is surgically resected in the first trimester, progesterone needs to be replaced to avoid pregnancy loss. Of those complex lesions diagnosed in the first trimester that persist into the second trimester, up to 10% may be malignant.
Providers who feel comfortable with laparoscopic techniques can proceed with minimally invasive surgery, with optimal timing in the early second trimester (J. Minim. Invasive Gynecol. 2011;18:720-5). Care should be taken to consider fundal height when choosing trocar placement. If there is a high suspicion for malignancy, providers may want to proceed via laparotomy, which should be via a vertical midline incision. Tocolytic therapy given prophylactically at the time of surgery has no proven benefit and should not be routinely administered.
Washings should be obtained and providers should perform a thorough inspection of the abdomen, contralateral ovary, omentum, and peritoneal surfaces. Any suspicious lesions should be biopsied. A simple cystectomy is reasonable with benign lesions; however, a unilateral salpingo-oophorectomy should be performed with frozen confirmation if there are any concerning findings for malignancy. If a malignancy is confirmed, a gynecologic oncologist should be consulted, and surgical staging should be considered.
Dr. Sullivan is a chief resident in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Gehrig is professor and director of gynecologic oncology at the university. Dr. Clarke-Pearson is the chair and the Robert A. Ross Distinguished Professor of Obstetrics and Gynecology, and a professor in the division of gynecologic oncology at the university. Dr. Sullivan, Dr. Gehrig, and Dr. Clarke-Pearson said they had no relevant financial disclosures.
